Irish government life sciences pledges welcomed by industry bodies

The programme for government was published on 15 January following talks between two political parties, Fianna Fáil and Fine Gael, which have now entered into a coalition agreement. The programme contains further pledges in relation to life sciences, intellectual property rights and innovation.

The new national life sciences strategy ties in to the government’s plans to enhance relationships with the US under the new Trump administration. Notably, there is a pledge to boost staffing levels in Enterprise Ireland and IDA Ireland to complement Ireland’s diplomatic presence in the US, with a specific focus on digital and life sciences, aimed at maximising opportunities in these areas.

Industry groups across the pharmaceutical sector have reacted to the new government’s pledges in relation to access to healthcare and medicines, including Medicines for Ireland (MFI) and the Irish Pharmaceutical Healthcare Association (IPHA).

MFI is the established industry voice within the Irish healthcare system, representing the role and interests of manufacturers and suppliers of generic, biosimilar, and value added medicines.

The IPHA represents the international research-based pharmaceutical industry in Ireland and comprises of member companies who are responsible for developing, manufacturing and bringing innovative medicines to Irish patients.

Some of the commitments contained in the newly published Programme for Government which have been welcomed by MFI and the IPHA are the pledge to implement the Mazars review recommendations, ensuring the medicine approval process is well-resourced for more timely patient access, and the commitment to review the drugs reimbursement process – MFI members have highlighted the importance of this as part of the negotiations on the framework agreement for the supply and pricing of medicines.

Further pledges to have won their support include the government’s commitment to investigate new methods for earlier reimbursement of certain treatments, including early access schemes for rare diseases; the aim to advance the digital infrastructure of the healthcare industry; and the commitment to increase the number of clinical trials and examine how better to support clinicians, researchers, and support staff to focus on clinical trial activities.

“The pledges are quite general, as is to be expected at this stage, but it is clear that the government recognises the continuing importance of the life sciences sector to the Irish economy and plans for future growth,” said Karen Gallagher of Pinsent Masons.

“The government appears focussed on adopting policies to improve the efficiencies of the medicines approval and reimbursement processes to improve patient access to drugs. The prospect of a more efficient, and more digital, system in relation to reimbursement and pre-launch regulatory requirements will appeal to both originator and generics & biosimilar pharmaceutical companies. The government also seems keen to encourage companies to carry out R&D activities in Ireland. It will be interesting to see what practical policies result from these pledges, and if we will see more studies and trials being carried out in Ireland for originator medicines, as well as for generics or biosimilars, under the Bolar exemption,” she said.

Hannah McLoughlin, also of Pinsent Masons in Dublin, added: “There is no specific reference to the Unified Patent Court, although we can expect industry groups to push for this to be put back on the new government’s agenda, given that there is a commitment in the programme for government to provide support for intellectual property rights for medicines to drive innovation and competitiveness.”